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510(k) Data Aggregation

    K Number
    K024290

    Validate with FDA (Live)

    Device Name
    PROMOTOR FINAL RINSE SPERM WASH MEDIUM
    Manufacturer
    CERES FERTILITY, INC.
    Date Cleared
    2003-03-03

    (70 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Promotor Final Rinse Sperm Wash is to be used as a sperm processing medium in washing procedures and for transport of sperm during reproductive technology procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a set of FDA letters regarding a product called "Promotor Final Rinse Sperm Wash Medium" and does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory approval letter, not a clinical study report. Therefore, I cannot fulfill your request based on the given input.

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